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Job Function:

Strategy & Corporate Development

Job Sub** **Function:

Strategic Partnerships & Alliances

Job Category:

People Leader

All Job Posting Locations:

Santa Clara, California, United States of America

Job Description:

Johnson & Johnson is hiring for a Sr. Director, Quality Operations and Supplier Quality for Shockwave Medical Inc. located in Santa Clara, CA.

The Sr. Director of Quality Operations and Supplier Quality provides leadership for the organization’s Quality Operations and Supplier Quality groups.

Participates in decisions on scope of work, risk management, length of tasks and compliance pathways, as well as optimization of manufacturing processes.

The Sr. Director participates in design changes to provide quality strategy and guidance for revised specifications and is expected to provide developmental and technical guidance to the team. The Sr. Director also develops and implements procedures and systems to assure Shockwave Medical complies with applicable regulatory standards such as:

• ISO 13485 – Medical Devices – Quality Management Systems

• ISO 14971 – Medical Devices – Application of Risk to Medical Devices

• 21 CFR Part 820 – Quality System Regulation

• 21 CFR Part 803 – Medical Device Reporting

• FDA Current Good Manufacturing Practices (CGMPs)

• EU MDR – European Medical Device Regulation (MDR)

• Council of the European Communities Directive 93/42/EEC – Medical Device Directive

• MDSAP and other relevant geography regulations

Essential Job Functions

• Quality Operations

o Directly responsible for ongoing management and improvements to the following Quality Operations activities:

+ Quality Control and Engineering support for manufacturing and operations

+ Incoming inspection and Final product acceptance activities

+ Complaints investigation

+ Document Control

+ Equipment Control

o Collaborate with R&D and Manufacturing engineering on process improvement projects.

o Interface with Design Assurance, R&D and Manufacturing to interpret Engineering requirements, drafting, reviewing and approving inspection and manufacturing related documentation.

o Support new product design transfer into manufacturing.

• Supplier Management

o Oversee and manage the execution of Supplier Quality responsibilities such as Supplier Audits, Supplier Qualifications, Supplier Corrective Actions (SCARs), Supplier Change Assessments (SCAs), Non-conformance Reports (NCRs) for raw materials/components.

o Identify supplier risks and work with cross-functional teams to prevent and/or resolve issues which could interrupt business continuity.

o Support component qualification projects in collaboration with key business partners and the supplier’s applicable functional groups.

• Manufacturing Line Transfers

o Define Quality requirements and plan tasks needed to transfer manufacturing lines or manufacturing processes to Contract Manufacturers or other SWMI sites.

o Support the cross-functional team by contributing to planning, allocating technical resources, assisting with technical issues, and providing guidance on transfers.

o Define processes to monitor product quality and production rates at CMs and to act when issues arise.

• Management

o Identify resource needs and hire as dictated by business needs.

o Responsible for direct supervision of the Quality Operations and Supplier Quality Leadership teams including hiring, coaching, training and development of subordinates.

o Collaborate with business partners to define and document processes affecting cross-functional teams (e.g.: Design Assurance, R&D, Manufacturing.)

o Collaborate cross-functionally in the interpretation of regulatory and engineering requirements and educate and influence others on those requirements.

o Communicate critical issues to upper management and escalate accordingly.

• Plan, manage, and oversee the assessment and implementation of process changes (e.g.: capacity expansions, equipment) at suppliers or at Shockwave Medical Inc. (SWMI)

• Define KPIs and metrics for Operations and Supplier Quality and create/define systems to support the efficient collection and analysis of data for such KPIs and metrics.

• Assist with risk management process maintenance.

• Lead teams to investigate, perform root cause analysis and develop corrective actions.

• Maintain compliance of Operations and Supplier Quality activities to Business Unit, JnJ sector and corporate requirements.

• In conjunction with the VP, Quality, plan, develop, track and report on department goals and objectives, budget, hiring, and training and development.

• Support ongoing Quality System and Compliance activities (CAPAs, NCRs, Service Order Requests, Audits, Standards Gap Assessment etc.)

• Define and execute plans for post commercial Design Changes, Supplier changes, QMS integration and automation to achieve high standards of Quality.

• Other duties as assigned.

Requirements

• BS degree in a related engineering discipline and 15+ years of related experience, or MS degree (preferred) in a related engineering discipline and 12+ years of related experience.

• 5+ years of experience managing others and leading teams.

• Strong understanding of cGMP, FDA 820 QSR, ISO 13485.

• Prior experience in product design transfers/ manufacturing line transfers.

• Effectively supervise, manage, and develop teams.

• Successfully work in a fast-paced environment while managing multiple priorities.

• Initiate and/or lead projects and successfully drive projects to completion.

• Strong decision making with minimal information while maintaining an understanding of risks and outcomes.

• Strong leadership, analytical and problem-solving skills.

• Excellent communication skills

• Ability to travel up to 20% of the time.

• Relevant certifications (eg: Lead Auditor, Six Sigma, Project Management, CQE) are a plus.

• Ability to speak Spanish is a plus.

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center ([email protected]) or contact AskGS to be directed to your accommodation resource.

The anticipated base pay range for this position is :

$200,000 - $343,850USD

Additional Description for Pay Transparency:

The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year. Bonuses are awarded at the Company’s discretion on an individual basis. Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Company’s long-term incentive program. Employees are eligible for the following time off benefits: Vacation – up to 120 hours per calendar year Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year Holiday pay, including Floating Holidays – up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year Additional information can be found through the link below. http://www.careers.jnj.com/employee-benefits The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.